This is a prospective, controlled, randomized, and open-label clinical trial conducted at Alexandria University Hospitals to compare the efficacy of diosmin-hesperidin versus loratadine, and their combination, for the prevention of G-CSF-induced bone pain in adult patients (18-65 years) with hematological malignancies (leukemia or lymphoma) receiving filgrastim.
Rationale:
G-CSF-induced bone pain is a common and debilitating side effect, impacting patient quality of life. While current management strategies using NSAIDs and antihistamines are not always sufficient, diosmin, a flavonoid with known anti-inflammatory and neuroprotective properties, has not been thoroughly investigated for this indication. This study aims to address this gap and explore the potential of diosmin, loratadine, and their combination to mitigate G-CSF-induced bone pain.
Study Design:
Participants meeting the eligibility criteria (detailed elsewhere) will be randomly assigned to one of four treatment groups:
Control Group: No specific treatment for bone pain. Loratadine Group: Loratadine 10mg tablet once daily, administered 30 minutes before filgrastim and continued for 5 days.
Diosmin-Hesperidin Group: Diosmin-Hesperidin 500mg tablet twice daily, administered 30 minutes before filgrastim and continued for 5 days.
Combination Group: Loratadine 10mg tablet once daily plus Diosmin-Hesperidin 500mg tablet twice daily, administered 30 minutes before filgrastim and continued for 5 days.
Filgrastim will be administered according to standard clinical practice for the underlying hematological condition.
Assessments:
Baseline Assessment: Before the start of filgrastim administration, demographic data, medical history (including type of malignancy, comorbidities, prior G-CSF treatment, and chemotherapy details), baseline laboratory tests (CBC, CRP, liver and kidney function), and baseline pain assessment using the Brief Pain Inventory (BPI) will be collected.
Follow-up Assessments:
Within 24 hours of the first filgrastim dose, pain will be assessed using the BPI, and baseline TNF-alpha levels will be measured.
After 5 days of treatment, follow-up laboratory tests (including TNF-alpha levels) and pain assessment using the BPI will be conducted.
Primary Outcome:
The primary outcome is to compare the effectiveness of diosmin-hesperidin, loratadine, and their combination in preventing G-CSF-induced bone pain. This will be assessed by changes in pain frequency and severity (measured by the BPI) and changes in serum TNF-alpha levels.
Secondary Outcome:
The secondary outcome is to identify risk factors associated with the frequency and severity of G-CSF-induced bone pain.
Statistical Analysis:
Data will be analyzed using IBM SPSS version 26. Appropriate statistical tests will be used to compare the treatment groups and assess the relationships between variables.
Ethical Considerations:
The study will be conducted in accordance with the Declaration of Helsinki and will be subject to approval by the Ethics Committee of Alexandria University. All participants will provide written informed consent before enrollment.
